Date: 20100125
Docket: T-1983-08
Citation:
2010 FC 81
Toronto, Ontario, January 25, 2010
PRESENT: The Honourable Mr. Justice Zinn
BETWEEN:
JANSSEN-ORTHO INC. and
ALZA CORPORATION
Applicants
and
APOTEX INC. and
THE MINISTER OF HEALTH
Respondents
REASONS FOR ORDER
AND ORDER
[1]
Separate
motions were heard together in Court files T-1983-08 and T-775-09, which
involve the same parties and arise out of twin applications. The applications
are made pursuant
to the Patented
Medicines (Notice of Compliance) Regulations, SOR/93-133, as amended (NOC
Regulations) with respect to a methylphenidate product for which Apotex Inc.
(Apotex) seeks Notices of Compliance from the Minister. These applications
have been agreed to be consolidated and are scheduled to be heard commencing
April 12, 2009. Given the similarity of the motions, the reasons in both are
identical, although separate Reasons for Order and Order will issue in each
file. Given the short time before hearing of these applications, my reasons
will be brief.
[2]
The
order of evidence in these applications was reversed. Apotex was required to
file first its evidence as to validity before the Applicants were required to
file their evidence. The normal order of evidence as to infringement was
maintained with Apotex responding to the Applicants’ evidence.
[3]
The Applicants
move to strike certain paragraphs and exhibits from the evidence of Apotex. All
of the impugned evidence was filed by Apotex in response to the Applicants’
evidence on infringement. It is submitted by the Applicants that the impugned paragraphs
and exhibits relate to the issue of the invalidity of Canadian Patent No.
2,264,852 (the ‘852 patent) and not to the issue of infringement of the ‘852
patent by the Apotex methylphenidate product.
[4]
The Applicants
assert that invalidity evidence filed by Apotex is interspersed throughout by
evidence in respect of non-infringement. If so, it is submitted, this violates
the Court’s scheduling Orders. The Applicants in their Notices of Motion ask
that this evidence be struck. In the alternative, the Applicants seek leave to
file reply evidence. If the evidence is not struck, then the Applicants ask
that the schedule for the completion of the steps to hearing be revised. This
last request for relief in the Notice of Motion was not pursued at hearing;
counsel for the Applicants advised the Court that regardless of the outcome of
this motion, the current scheduled hearing dates can be met.
[5]
Apotex
submits that the impugned evidence is appropriate non-infringement evidence,
not invalidity evidence. It submits that “virtually all of the impugned
evidence is in direct response to evidence raised for the first time by the
Applicants in their non-infringement evidence and Apotex is thus entitled to
lead it.” They submit that the Applicants have failed to meet the test for
reply evidence and that they should not be granted leave to file the proposed
affidavits of Kennerly Patrick and James Swanson.
[6]
A
few words are in order concerning motions to strike in NOC proceedings.
Prothonotary Aalto recently reviewed the jurisprudence of this Court relating
to motions to strike affidavit evidence in this context: see Proctor &
Gamble Pharmaceuticals Canada Inc. v. Canada (Minister of
Health), 2009
FC 113. I agree with his observation that such motions must be the exception
and that complaints about the evidence are best left to the hearing judge. In
my view, it is only where the evidence challenged is clearly improper, in the
sense that it is scandalous or vexatious, or it is without doubt abusive or
irrelevant, that the evidence ought to be struck prior to the hearing.
[7]
The
scheduling Orders of the Court are to be respected. In NOC proceedings, where
the order of evidence has been reversed, parties ought not to file evidence in
the second tranche that clearly and without question ought to have been filed
in the first tranche. To proceed in such a fashion would be a clear abuse of
the Court’s Orders and processes. However, in order to warrant a pre-hearing
motion and the time of the Court, the evidence about which a party complains must
clearly and without question relate only to the issue on which the party has
already filed its evidence. Accordingly, in this case, if the impugned evidence
clearly and without question relates only to validity, I am prepared to strike
it, notwithstanding that motions of this sort are to be discouraged.
[8]
I
turn to examine the impugned evidence.
John Hems Affidavit
[9]
The
Applicants seek to strike paragraph 12 of the affidavit of John Hems and the
exhibit referenced therein. That paragraph reads as follows:
I was further asked by Mr.
Clarizio [with the firm that is counsel to Apotex] to provide testing data, if
available, that Apotex possessed in relation to Ritalin SR. Attached as
Exhibit “F” to this my affidavit is a DVD containing a study that was done for
Apotex (“the bio-study”). The bio-study involved testing Ritalin SR and a
product that was developed by Apotex.
[10]
The
bio-study attached as an exhibit was not made a part of the record before the
Court on these motions but apparently runs to more than 3,000 pages. Apotex
asserts that only 20 pages of it, the pages referenced by Dr. Ping Lee, are
relevant.
[11]
It
is not stated by Mr. Hems why he produces the bio-study in his affidavit,
except to state that the lawyer for Apotex asked him. It is evident that it
was attached to his affidavit in order to properly identify it so others, Dr. Ping
Lee in fact, might speak to it. For that reason, the status of the bio-study
and paragraph 12 of Mr. Hems’ affidavit stands or falls with the evidence of Dr.
Lee that relates to the bio-study document.
David Greenblatt
Affidavit
[12]
The
Applicants submit that paragraphs 7 and 11 to 14 of Dr. Greenblatt’s affidavit
deal with ambiguity and thus are directed to validity. They point to the
following passages to illustrate their allegation:
- “Reference is
repeatedly made in these affidavits to the ambiguous and variable language
found in the ‘852 Patent.”
- “In the context of
the ‘852 Patent, it is my opinion that these terms are ambiguous…”
- “Thus, a phrase
such as “sustained ascending dose over time” would also, in my opinion,
have been ambiguous to the notional clinical psychologist …”
[13]
I
agree with the submissions of Apotex that these paragraphs are made in response
to the Applicants’ infringement evidence and that they relate to what is meant
by the phrase “sustained ascending dose over time” as used in the patent. This
evidence goes to the proper interpretation of the patent.
[14]
The
patent must be interpreted before issues of validity or infringement are determined.
There is no question that evidence going to interpretation was put forward by
Apotex earlier in its affidavits directed to validity. It was suggested that a
party should put all of its evidence on interpretation in the affidavits that
it files first, in cases where the order of evidence has been reversed; however,
there is no jurisprudence or rule that prevents a party from advancing evidence
that goes to interpretation in the second tranche. In my view, the Court ought
to consider such evidence, especially if it responds to something just filed by
the party opposite. I am satisfied that the impugned paragraphs meet that
test.
[15]
The
Applicants submit that paragraphs 38 to 45 of Dr. Greenblatt’s affidavit relate
to validity. Apotex submits that these paragraphs support the Gillette defence
it raised in its Notice of Allegation that its product would not infringe the
‘852 patent because it will be “made, constructed, used and sold in accordance
with the teachings of the prior art.” Therefore, it submits, it is obligated
to discuss that prior art, including Ritalin SR, which is the subject of the
paragraphs. The Applicants submitted that it is fallacious to state that
evidence related to the Gillette defence must relate to infringement and
provided the Court with an interesting interpretation of the grounding of that
defence in support of their view. That view is better left to be decided by
the hearing judge than a judge on a motion of this sort. I do not find that
these impugned paragraphs are clearly and without question related only to
validity. It was noted that counsel made the statement at the hearing that the
Patrick article cited at paragraph 41 is “in the main” related to invalidity. This
suggests that it is related in part to other aspects of the application; if so,
it should not be struck. For these reasons these paragraphs will not be struck
at this stage.
[16]
The
Applicants submit that paragraphs 57 and 62 relate to construction of the ‘852
patent and go to the issue of its validity in that it alleges that the figures
in the patent reflect artificial and not real profiles. Again, they relate in
part to construction of the claims, and therefore are not struck.
Ping Lee Affidavit
[17]
Paragraph
14 is alleged to be a statement that is in the nature of reply evidence and
thus inappropriate. Dr. Ping Lee begins this paragraph with the phrase “As
with earlier paragraphs, Dr. Davies in his paragraph 60 misses the point that I
was conveying…” and he then goes on to reiterate what his point was. I agree
with the Applicants that this paragraph is reply; it adds nothing new, and is
improper. It is struck.
[18]
At
paragraph 19, Dr. Lee speaks to two US patents and to the
statements made by Dr. Davies, the Applicants’ witness, concerning them. These
patents are prior art and it is submitted that the impugned paragraph must be
directed to validity. Apotex submits that they relate to its Gillette
defence. I am not convinced at this stage that the statements made in this
paragraph do relate to the Gillette defence and thus are saved as being
directed, in part, to infringement; however, Apotex ought to be able to make
that case to the hearing judge based on a complete record including
cross-examination and this paragraph is not struck.
[19]
The
Applicants submit that paragraphs 47 to 49 relate to claim 1 of the ‘852 patent
and the construction of the phrase “over time” and they point out that Dr. Lee
failed to raise this evidence in his first affidavit on construction. Much of
the impugned evidence responds directly to statements made by Dr. Patrick in
his affidavit filed on infringement or to its Exhibits “S” and “T”. Further,
the evidence appears to have some relevance to the construction of the ‘852
patent and thus will not be struck.
[20]
In
paragraph 50 Dr. Ping Lee refers to Exhibits “S” and “T” to the affidavit of
Dr. Patrick and then states that “these are not the only published papers where
Ritalin SR had a plasma profile that peaked at 4 hours or greater” and he then
goes on to point out that the article attached as Exhibit “U” to Dr. Patrick’s
affidavit also showed patients whose plasma profile peaked at 4 hours or
greater and concludes that “it is clear that the plasma levels for Ritalin SR,
in some instances, ascended continuously to 4 hours or more.” This statement
appears on its face to be responding to Dr. Patrick’s statements; however, it
does not challenge his evidence or contradict it. It is in fact not responding
at all to Dr. Patrick’s evidence. It’s only obvious relevance would be as
evidence of prior art that goes to the issue of validity. It has no obvious
connection either to infringement or to interpretation of the patent and is
struck. The statements made by Dr. Lee in this paragraph are more appropriate
for cross-examination of Dr. Patrick.
[21]
At
paragraphs 53 and 68 and Exhibit “B” Dr. Lee turns to the Apotex bio-study.
The Applicants describe this as evidence that is “post art” as it was done in
2003, well after the ‘852 patent. Apotex submits that this evidence “is in
response to paragraphs 99-103, and exhibits “S” and “T”, of Dr. Patrick’s
non-infringement affidavit.” It is said that it specifically addresses his
statement that “the ‘852 Patent refers to the plasma profile of the Ritalin-SR
formulation as “nonascending profile over time.” Through this post art Apotex challenges
the assertion that the plasma profile of Ritalin SR is a flat profile and it
says that it is a continuously ascending profile.
[22]
The
Applicants submit that there is no evidence that the Ritalin SR that was the
drug studied in the 2003 in the bio-study is exactly the same as that which
existed at the time the ‘852 patent issued and absent such evidence the study cannot
assist in interpretation of the ‘852 patent insofar as it discusses Ritalin
SR.
[23]
It
is not obvious to the Court that the Ritalin SR that was the subject of the
bio-study was not the identical formulation referenced in the ‘852 patent. A
more complete record, such as will exist at the hearing is required to assess
this submission’s merit. It is also not obvious to the Court that the impugned
evidence does not go to interpretation. Accordingly, it is not struck.
[24]
As
a consequence paragraph 12 and Exhibit “F” to the affidavit of John Hems are
also not struck.
Christopher Varley
Affidavit
[25]
A
challenge was made to paragraph 30 but was dropped at the hearing when it was
conceded by counsel that it could arguably relate to interpretation.
[26]
In
paragraphs 38 and 39 Dr. Varley discusses Metadate CD. In paragraph 38 his
statement regarding it begins with the phrase “I reiterate,” being a reference
to his earlier affidavit on validity.
[27]
Apotex
submits that these paragraphs relate to non-infringement. “At page 13 of
Apotex’s NOAs, Apotex stated that its product will not infringe the ‘852 Patent
because, among other things, it will not regulate and compensate for acquired
tolerance. Dr. Varley’s impugned affidavit is simply that the Metadate CD
product, which has a similar profile to the ‘852 Patent (and therefore,
according to the Applicants’ theory, to Apotex’s proposed product), does not
regulate tolerance.”
[28]
Infringement
requires that the Apotex product be compared to the ‘852 patent. Whether
Metadate CD does or does not regulate tolerance and whether it does or does not
have a profile similar to the ‘852 patent is entirely irrelevant to infringement
by the Apotex methylphenidate product. I also reject the submission that this
evidence goes to interpretation of the phrase “sustained ascending dose” as not
referring to plasma on the basis that Metadate CD has an ascending plasma
profile but there is no discussion that it might regulate tolerance. There is
no connection between the impugned paragraphs and the interpretation of the
‘852 patent. It is lastly submitted that these paragraphs respond to Dr.
Gonzáles who introduced Metadate CD in his affidavit. It is true that Dr.
Gonzáles mentions Metadate CD; however, his reference to Metadate CD is at
paragraph 11 of his affidavit wherein he describes his experience in the
research and development of methylphenidate dosage forms. As such, while it is
mentioned in his affidavit, there is nothing therein that requires the response
provided.
[29]
The
Applicants submit that if these paragraphs are permitted to stand then they
should be permitted to reply to them as they could not have been reasonably
anticipated by them. I agree. However, given the irrelevance of the evidence
in these impugned paragraphs to the issue of interpretation or
non-infringement, I conclude that the proper course is to strike them.
[30]
The
Applicants object to paragraph 59. Dr. Varley makes two comments therein. The
first is his opinion that the Applicants’ experts are giving terms meanings that
are “not clearly defined within the body of the ‘852 Patent.” Secondly, he
reiterates his position from his first affidavit that these terms are capable
of multiple meanings. While this evidence may be redundant, it goes to
interpretation not to validity and is not struck.
[31]
In
paragraph 61, Dr. Varley returns to the Applicants’ experts’ evidence and says
that he finds it difficult to accept their interpretations “based on what is
described in the patent” and concludes that as the ‘852 patent is “providing
‘mixed’ messages, the patent simply is not clear on what the invention actually
is.” This paragraph alleges the patent is ambiguous and thus goes to invalidity.
It is struck.
Reza Fassihi Affidavit
[32]
The
Applicants submit that paragraphs 29 to 31 are improper as relating to
validity. Apotex submits that these paragraphs respond to Dr. Davies’
affidavit, and in particular to paragraph 22 wherein his discusses the words
“dose” and “sustained-ascending dose”. While Dr. Davies’ affidavit is directed
to both validity and infringement, his paragraph 22 is directed to
interpretation of the ‘852 patent, and in my view, Dr. Fassihi is entitled to
respond to that interpretation.
Reply Evidence
[33]
Rule
312(a) of the Federal Courts Rules permits this Court to grant leave to
file additional evidence. In Atlantic Engraving v. Lapointe Rosenstein, 2002
FCA 503 at paras. 8-9, the Court of Appeal described four requirements that
must be met before this Court may permit additional affidavits:
(a)
The
evidence to be adduced will serve the interests of justice;
(b)
The
evidence will assist the Court;
(c)
The
evidence will not cause substantial or serious prejudice to the other side; and
(d)
The
evidence must not have been available at an earlier date.
In Deigan v. Canada (Industry) (1999), 168
F.T.R. 277 (T.D.) aff’d (1999), 165 F.T.R. 121 (T.D.), a fifth requirement was enunciated:
The evidence will not unduly delay the proceeding. These five criteria were
applied in Merck Frosst Canada & Co. v. Canada (Minister of
Health),
2003 FCT 287 at para. 12 and Pfizer Canada Inc. v. Canada (Minister of
Health),
2007 FC 168 at para. 5.
[34]
Apotex
submits that the proposed reply evidence was available at an earlier date, that
supplementing the record will unduly delay the proceeding, that it will result
in prejudice to its interests, and that the interests of justice should favour
not permitting the filing of the proposed affidavits.
[35]
In
view of my disposition of paragraphs 38 and 39 of Dr. Varley’s affidavit, the Applicants
admit that no reply affidavit is required from Dr. Swanson. The Court need
only consider Dr. Patrick’s proposed reply affidavit.
[36]
With
one exception, the Applicants have not demonstrated that the proposed evidence
of Dr. Patrick was not previously available or could not have been anticipated
as relevant. I agree with Apotex that many of the proposed paragraphs from Dr.
Patrick simply reiterate or rephrase his earlier evidence. Much of the
proposed evidence relates to matters more appropriate for cross-examination of
the affiants his proposed affidavit addresses. I have reviewed his proposed
affidavit with care and have concluded that the only part of his proposed
affidavit that could not be reasonably anticipated by the Applicants to be
relevant when they filed their evidence and which could assist the Court are
the paragraphs relating to the Apotex bio-study, i.e. paragraphs 25 to 30.
Accordingly, the Applicants are granted leave to file reply evidence from Dr.
Patrick consisting of paragraphs 25 to 30 of the proposed affidavit, together
with the necessary introductory paragraphs.
Costs
[37]
In
view of the divided success on the motion, there will be no costs awarded.
ORDER
THIS COURT ORDERS that:
1.
Paragraphs
14 and 50 of the affidavit of Dr. Ping Lee are struck;
2.
Paragraphs
38, 39 and 61 of the affidavit of Christopher Varley are struck;
3.
The
Applicants are granted leave to file reply evidence consisting of paragraphs 25
to 30 of the proposed affidavit of Dr. Patrick, together with the necessary
introductory paragraphs; and
4.
No
costs are awarded.
“Russel
W. Zinn”
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